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PHASE 2 TRIAL RESULTS
This double-blind, placebo-controlled study was designed to determine the efficacy and safety of GT20029 for treating male androgenic alopecia (AGA) and the recommended dosage for a Phase 3 trial.Details and results of the completed trial are as follows (as reported through a press release):
- The study included 180 male patients with AGA.
- The patients were split into once-daily (“QD”) or twice-daily (“BIW”) groups, each with its control (placebo) or dosing (0.5%/1%) group.
- Mean non-vellus target area hair count (TAHC) was measured at baseline and endline.
- The 0.5% “QD” GT20029 group showed an increase of 16.8 hairs/cm2 (an increase of 6.69 hairs/cm2 over the placebo), which was a statistically significant increase (P <0.05).
- The 1% “BIW” GT20029 group showed an increase of 11.94 hairs/cm2 (an increase of 7.36 hairs/cm2 over the placebo), which was a statistically significant increase (P<0.05).
- The topical treatment showed good safety and tolerability, with adverse events comparable to the placebo’stor has identified the 1% “BIW” dosage as the optimal dose for its Phase 3 trial in China.
